Medical sphincterotomy has gained popularity as a treatment for anal fissure. Ca channel blockers in topical forms may be appropriate treatment with low adverse effect. This study designed for comparing topical and oral nifedipine in treatment of chronic anal fissure. Methods: A prospective randomized controlled trial was conducted on 60 patients in topical nifedipine (0.5%) and 59 patients in 10 mg/TDS oral nifedipine. Patients were assessed on regular visit for pain score, blood pressure, pulse rate, healing of ulcer bed and side effects. The ultimate follow up period was 6m.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104166200N1
Registration date:2012-11-16, 1391/08/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-16, 1391/08/26
Registrant information
Name
Farzaneh Golfam
Name of organization / entity
Shahed University, Medicine faculty
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 9437
Email address
golfam@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
grant
Expected recruitment start date
2002-02-20, 1380/12/01
Expected recruitment end date
2007-02-20, 1385/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of topical Nifedipine with oral Nifedipine for treatment of anal fissure: A randomized controlled trial
Public title
The effect of Nifedipine for treatment of anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: chronic anal fissure patients. Exclusion criteria: patients had history of sexually transmitted disease, TB, IBD, or medically related conditions such as gestation, migraine, cardiovascular and other chronic diseases, anorectal surgery or another anorectal disease.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
119
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medicine faculty of Shahed university
Street address
Ebadollah zade street, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
7
Health conditions studied
1
Description of health condition studied
chronic anal fissure
ICD-10 code
k60.1
ICD-10 code description
Chronic anal fissure
Primary outcomes
1
Description
ulcer healing in anal fissure
Timepoint
4 weeks (traetment period), 6 months (follow up)
Method of measurement
visual score
Secondary outcomes
1
Description
headache
Timepoint
2 months, 6 months
Method of measurement
visual, patient ducument
2
Description
blood pressure and pulse rate
Timepoint
2 months, 6 months
Method of measurement
sphygnomanometer, physical exam, patient ducument
Intervention groups
1
Description
Nifedipine cream (0.5%) for 4 weeks
Category
Treatment - Drugs
2
Description
10 mg of Nifedipine TDS for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mostafa Khomeini Hospital
Full name of responsible person
Farzaneh Golfam
Street address
Italy street, Keshavarz BLVD
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed Unniversity, Medicine faculty
Full name of responsible person
Marjan Heshmati
Street address
Shahid Ebadolahzade street, Keshavarz BLVD
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?